FDA-Device2018-05-23Class II
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Siemens Medical Solutions USA, Inc
Hazard
There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and SOMATOM Force.
Sold states
Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.
Affected count
91
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1748-2018Don't want to check this manually?
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